Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants

NCT ID: NCT06582563

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-08-30

Brief Summary

Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).

Detailed Description

Primary objectives of the planned whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).

Conditions

Blood Coagulation Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Whole Blood Clotting Time

Comparator

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• In general, study participants must:

1. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.

2. Be 18- to 80-years-of-age, inclusive, at time of consent.

3. Have suitable venous access for at least a single venipuncture.

4. Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion

Exclusion Criteria

• Eligible patients on anticoagulants must not:

1. Other than the condition for which a DOAC was prescribed , have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions.

2. Have a BMI> 40 or weight > 120kg.

3. Suffer from renal or hepatic insufficiency.

4. Suffer from any pathology that would contra-indicate in general DOAC medication.

5. Have a history of unexplained syncope.

6. Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).

7. Consume more than 5 cigarettes per day.

8. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).

9. If female is pregnant, breastfeeding, or planning to become pregnant during study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Perosphere Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven Hospital

Leuven, , Belgium

Countries

Belgium

Central Contacts

Peter Verhamme, Professor

Role: CONTACT

peter.verhamme@uzleuven.be

3216343491

Sasha Bakhru, PhD

Role: CONTACT

s.bakhru@perospheretech.com

475 237-4178

Facility Contacts

Peter Verhamme, Professor

Role: primary

peter.verhamme@uzleuven.be

3216343491

Sasha Bakhru, PhD

Role: backup

s.bakhru@perospheretech.com

Other Identifiers

CP-01-02-002

Identifier Type: -

Identifier Source: org_study_id